Brian King, director of the Center for Tobacco Products (CTP) at the U.S. Food and Drug Administration (FDA), issued an announcement. Here’s a summary of the announcement:
In response to the report of an independent panel of experts organized by the Reagan-Erdell Foundation (RUF) on the evaluation of our Center, including our plan to address the 15 recommendations made in the evaluation, I announced a “full center” approach to the CTP in February of this year. We immediately started to implement the blueprint set out in the statement and made important progress.
Below is a summary of our progress and next steps. A detailed updated list of each recommendation can be found on the updated web page, Action in Response to the Reagan-Erdell Recommendations for assessing CTP.
Horizontal integration
A key recommendation in the report is the creation of a new strategic plan, which the CTP is fully committed to developing. I am pleased to report that the CTP plans to issue proposed targets this summer and a final plan in December 2023.
Over the past few months, the Center’s leadership at all levels has met and had fruitful discussions on the Center’s direction and development of this important program, including ways to advance health equity in various program areas. This effort is supported by colleagues in the Office of Planning, Evaluation, and Risk Management in the FDA’s Office of Operations. As part of the development process, CTP is seeking input from employees. Public input is equally important, and we plan to hold a public meeting in summer 2023 to solicit stakeholder feedback on the strategic plan.
Another horizontal recommendation in the report focuses on transparency, which is the guiding principle in all our efforts. Internally, the CTP’s Transaction Processing Office is leading the development of an operational strategy to improve transparency and information sharing across all program areas, including through the establishment of a transparency liaison. Externally, the center is planning upcoming public meetings to gather stakeholder input. The CTP has also published a web page listing all citizen petitions received by the Center related to tobacco products so that the public can easily access and use the relevant information. In addition, the page on “Request a CTP Speaker” has been updated to list my presentations at public talks and information on how to request slides for my presentations.
Science and application review
The Center has reviewed more than 26 million applications for tobacco products over the past three years and has made significant progress, completing reviews of 99 percent of the applications. As part of these reviews, the CTP has approved 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products that can be legally sold or distributed.
We recognize the opportunity to improve the application review process and are committed to engaging meaningfully with our stakeholders to solicit their feedback on this matter. To that end, the CTP is currently planning a public meeting in the fall of 2023 to discuss the application review process. More information about this public meeting will be available soon.
During this time, the leadership of the CTP Office of Science is committed to attending conferences and external meetings, providing information about the review process and answering questions. For example, representatives from the Office of Science have recently spoken at conferences such as the Food and Drug Law Institute’s Scientific Symposium on Nicotine Product Regulation, the Tobacco Chamber of Commerce Annual Meeting, and the e-Cigarette Summit. We are also preparing, as needed, to publish on our website scientific memos that may be helpful to applicants from 2019 to the present and to develop new memos on a variety of topics.
We are also working to address recommendations related to the Tobacco Products Scientific Advisory Committee (TPSAC). In May, the TPSAC met for the first time at the FDA’s White Oak campus to discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practices.” The meeting is open to the public, and the proposed rules are currently open for public comment until Sept. 6, 2023. We are working to ensure that TPSAC continues to provide valuable input and plan to meet at least once a year to cover a wide range of scientific issues involving pre-market assessments.
Regulations and guidance
The Center is in the final stages of finalizing regulations on menthol cigarettes and flavored cigars and continues to work on issuing a proposed rule to establish a maximum nicotine content to reduce the addictiveness of cigarettes and certain other burned tobacco products. As mentioned above, the CTP has also recently proposed new requirements for tobacco product manufacturers through the proposed rule, “Tobacco Product Manufacturing Practice Requirements.” In addition to the TPSAC meeting described above, the CTP held a consultation meeting with indigenous communities on April 11 to get their views on the regulation, and a public oral hearing on April 12 to provide the public with an opportunity for written comments.
Following the recommendations in the report, the Centre has begun the process of establishing a policy unit within the Office of the Director of the Centre, which will be responsible for the overall coordination of policy work within the CTP. In addition, the Center plans to issue a policy agenda by the end of the year and plans to solicit stakeholder input on this issue at upcoming public meetings and through Federal Register notices.
Compliance and enforcement
As I have mentioned many times in the past, CTP will not stand by and watch manufacturers, retailers or distributors sell illegal products, especially those that are known to appeal to young people. From January 2021 to June 2023, the CTP issued more than 570 warning letters and took multiple enforcement actions, including filing 13 civil penalty lawsuits and six injunctions through the Department of Justice (DOJ) against companies selling illegal vaping products. In the past few weeks, the center has moved quickly to restrict the sale of illegal disposable e-cigarette products that appeal to young people. These actions included issuing warning letters to two companies responsible for manufacturing, distributing and importing Esco Bars and Breeze products, as well as to more than 200 retailers illegally selling various types of Puff, Hyde, Elf Bar and Esco Bars products. All of these actions are part of the Center’s ongoing compliance and enforcement portfolio, demonstrating our commitment to firmly enforcing the law throughout our supply chain – from manufacturers to retailers.
The Department of Justice is an important partner in FDA’s compliance and enforcement efforts. Senior officials from the Office of the Director of the Department of Health and Human Services (HHS), including the Office of the FDA’s Chief Counsel, the Office of the FDA Commissioner, the CTP, and the Department of Justice are working closely together to discuss issues related to enforcement. Further discussions are expected to take place this summer.
In addition to discussions with the Department of Justice, we have ongoing meetings with federal partners, including the Federal Bureau of Investigation (ATF), the Federal Trade Commission (FTC), and U.S. Customs and Border Protection (CBP). These meetings are designed to facilitate information sharing and coordination to strengthen our regulation and enforcement of the tobacco products market.
In terms of public education, CTP continues its efforts to provide information and resources to help consumers understand the risks of tobacco products. We recently released a new consumer update highlighting the risks of e-cigarette products and the steps we are taking to protect young people from the lure of tobacco products. We also work with the media to jointly launch campaigns and advertisements to raise public awareness of the risks of tobacco products.
Sum up
This announcement summarizes the progress and next steps made by the FDA’s Center for Tobacco Products in response to the Reagan-Erdell Foundation Independent Panel assessment. The Center is implementing a whole-of-center approach, including work on horizontal integration, science and application review, regulation and guidance, compliance and enforcement, and public education. The Center will continue to work to ensure transparency, scientific accuracy and fairness, and work with stakeholders to improve the regulation of tobacco products.
References:
【1】CTP’s Progress Addressing Recommendations from the Reagan-Udall Evaluation